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Decision of investigational team
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Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.
The patient will conduct functional testing and answer questionnaires.
The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.
To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ConforMIS iTotal Knee replacement | Active Comparator | iTotal patient-specific knee replacement system |
|
| DePuy total knee replacement | Active Comparator | Off the shelf knee replacement system |
|
| Zimmer total knee replacement | Active Comparator | Off the shelf knee replacement system |
|
| Biomet total knee replacement | Active Comparator | Off the shelf knee replacement system |
|
| Smith & Nephew total knee replacement | Active Comparator | Off the shelf knee replacement system |
|
| Stryker total knee replacement | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Off the Shelf Total Knee Replacement | Device | A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | Comparing the functional testing differences between iTotal and off the shelf. "Total Functional Activities Score" - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are made for factors that limit a patient's mobility, such as needing to use an ambulatory device. The subscale scoring system ranges from 0-100, with higher scores indicating better knee function. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes. "Patient Satisfaction", a subscale within the Knee Society Score (KSS), was utilized to capture this metric. The Patient Satisfaction subscale combines scores given for certain responses (very satisfied, satisfied, neutral, somewhat dissatisfied, very dissatisfied) across 5 questions. These questions are designed to determine the level of satisfaction a patient has with their implant across both everyday and active activities. This score ranges from 0-40, with higher scores indicating higher levels of patient satisfaction. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Mary O'Connor, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California in San Diego | La Jolla | California | 92037 | United States | ||
| Sharp Healthcare |
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While "Biomet Total Knee Replacement" and "Smith and Nephew Total Knee Replacement" Arms/Groups were listed as possible study groups, no included patients utilized these implant systems. This included patients who failed to meet screening criteria, failed to reach the protocol's required follow-up duration, etc. These arms/groups were only established before the study to represent the possible study groups based on available implant systems on the market.
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| ID | Title | Description |
|---|---|---|
| FG000 | ConforMIS iTotal Knee Replacement | iTotal patient-specific knee replacement system ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs. |
| FG001 | DePuy Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| FG002 | Zimmer Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| FG003 | Biomet Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| FG004 | Smith & Nephew Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| FG005 | Stryker Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Our analysis expected a broader range of off the shelf implants, but no included patients received Biomet or Smith & Nephew Total Knee Replacements.
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| ID | Title | Description |
|---|---|---|
| BG000 | ConforMIS iTotal Knee Replacement | iTotal patient-specific knee replacement system ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs. |
| BG001 | DePuy Total Knee Replacement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | Comparing the functional testing differences between iTotal and off the shelf. "Total Functional Activities Score" - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are made for factors that limit a patient's mobility, such as needing to use an ambulatory device. The subscale scoring system ranges from 0-100, with higher scores indicating better knee function. | Patients that met inclusion criteria and had KSS Total Functional Activities Score. | Posted | Mean | Standard Deviation | Score on a subscale | 1 year |
|
1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ConforMIS iTotal Knee Replacement | iTotal patient-specific knee replacement system ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SAS | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedure Related Complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara Mann - Director of Clinical Affairs | restor3d | (984) 888-0593 | clinicalresearch@restor3d.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2017 | Aug 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Site staff that is performing functional testing on subject is blinded to what implant the patient has.
Off the shelf knee replacement system
|
| ConforMIS iTotal Knee Replacement | Device | A knee replacement performed with patient specific implant and surgical jigs. |
|
| 1 year |
| Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | All complications were stratified according to clinicaltrials.gov reporting standards and each site labeled each complication as either device-related, non-device-related, procedure-related, and non-procedure-related. | 1 year |
| San Diego |
| California |
| 92123 |
| United States |
| Denver-Vail Orthopedics | Parker | Colorado | 80134 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
| Tufts University | Boston | Massachusetts | 02111 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| OrthoNY | Albany | New York | 12205 | United States |
| The Lindner Center for Research and Education | Cincinnati | Ohio | 45219 | United States |
Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| BG002 | Zimmer Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| BG003 | Biomet Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| BG004 | Smith & Nephew Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| BG005 | Stryker Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| BG006 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
iTotal patient-specific knee replacement system ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs. |
| OG001 | DePuy Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| OG002 | Zimmer Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| OG003 | Biomet Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| OG004 | Smith & Nephew Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
| OG005 | Stryker Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker |
|
|
| Secondary | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes. "Patient Satisfaction", a subscale within the Knee Society Score (KSS), was utilized to capture this metric. The Patient Satisfaction subscale combines scores given for certain responses (very satisfied, satisfied, neutral, somewhat dissatisfied, very dissatisfied) across 5 questions. These questions are designed to determine the level of satisfaction a patient has with their implant across both everyday and active activities. This score ranges from 0-40, with higher scores indicating higher levels of patient satisfaction. | Patients that met inclusion criteria and had patient satisfaction data were included. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| Secondary | Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | All complications were stratified according to clinicaltrials.gov reporting standards and each site labeled each complication as either device-related, non-device-related, procedure-related, and non-procedure-related. | No included patients utilized the Biomet or Smith & Nephew total knee replacement systems. | Posted | Number | Patients with Events | 1 year |
|
|
|
| 0 |
| 81 |
| 13 |
| 81 |
| 26 |
| 81 |
| EG001 | DePuy Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker | 0 | 28 | 6 | 28 | 7 | 28 |
| EG002 | Zimmer Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker | 0 | 19 | 2 | 19 | 1 | 19 |
| EG003 | Biomet Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Smith & Nephew Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Stryker Total Knee Replacement | Off the shelf knee replacement system Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker | 0 | 19 | 0 | 19 | 7 | 19 |
| Infection-related Complication | Infections and infestations | Systematic Assessment |
|
| Wound Complications | General disorders | Systematic Assessment |
|
| Thrombotic Complications | Vascular disorders | Systematic Assessment |
|
| Pain/Stiffness Complications | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| 1 Year Score |
|
| Change in Score |
|
| Device Related Complications (including revision) |
|